Clinical Research Director jobs in Lincoln, NE

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Director, Clinical Site
  • Velocity Clinical Research, Inc.
  • Grand Island, NE FULL_TIME
  • Overview

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

     

    As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

     

    Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

     

    Summary:

    • The Clinical Site Director is responsible for managing the overall business and clinical operations of the site to ensure that appropriate targets are met. The Clinical Site Director is responsible for managing the site’s annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials. The Clinical Site Director oversees and manages all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct and regulatory compliance. The Clinical Site Director is responsible for ensuring the health and safety of study patients and staff.

    Responsibilities

    Duties/Responsibilities:

    • Work with the Senior Director of Clinical Operations to manage the operational budget and meet/exceed the site’s financial, operational, and study-specific targets.
    • Maintain complete (24/7) control over the overall operations and management of clinical research trials at the site
    • Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business and growth plans
    • Oversee the implementation and maintenance of Velocity quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs and Velocity SOPs
    • Work with the Medical Director to address any study and/or clinical quality related
    • Ensure timely and appropriate communications occur with Sponsors, CROs and IRBs as necessary
    • Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
    • Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
    • Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met.
    • Responsible for the assurance of all site staff complete required trainings.
    • Establish and communicate performance expectations and guidelines to site staff
    • Facilitate annual performance evaluation process with site staff.
    • Identify and manage issues, concerns and problems related to staff conduct and
    • Identify and build relationships with outside medical practices, pharmacies, and other health care professionals/organizations to aid in the patient recruitment process.
    • Conduct business development activities on behalf of the site and Velocity with sponsors, CROs, CRAs and any third-party study vendors, as appropriate.
    • Responsible for overseeing the proper reporting of site revenues, preparation of financial projections, invoicing to sponsors/CROs, and A/R collections.
    • Share best practices with other Velocity site locations with the goal of raising the overall level of operational competencies at Velocity.
    • Ensure completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation.
    • Attending industry and Velocity meetings relevant to the position of
    • Manage facility and IT needs to ensure smooth and efficient

    Qualifications

    Required Skills/Abilities:

    • Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through
    • Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-
    • Extensive knowledge of clinical research - Understands the drug development
    • Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
    • Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
    • Computer skills - Working knowledge of MS Office suite, Clinical Conductor CTMS and relevant CRM Able to generate business correspondence, create forms and generate reports as required.
    • Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
    • Ability to communicate effectively in English (both verbal and written).
    • Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
    • Other duties as

    Education and Experience:

    • Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research
    • 5 years of clinical management experience or equivalent applicable experience in clinical research industry

    Physical Requirements:

    • Prolonged periods of sitting at a desk and working on a
    • Must be able to lift up to 15 pounds at

     

    NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

  • 20 Days Ago

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Clinical Research Coordinator
  • Revival Research Institute, LLC
  • Lincoln, NE FULL_TIME
  • Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since...
  • 1 Month Ago

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0 Clinical Research Director jobs found in Lincoln, NE area

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Graduate Assistant (Counseling)
  • Nebraska State College System - Chadron, Peru, and Wayne State
  • Lincoln, NE
  • Posting Details Position Information Job Title Graduate Assistant (Counseling) Rank Graduate Assistant Tenure Informatio...
  • 3/28/2024 12:00:00 AM

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Banquet Supervisor for a Downtown Hotel
  • Hilton Garden Inn Lincoln Downtown/Haymarket
  • Lincoln, NE
  • We are looking for a motivated individual to join our team as a Banquet Supervisor. What we can offer YOU!: -Free Parkin...
  • 3/28/2024 12:00:00 AM

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TeleSales Specialist -Remote
  • InsuraTec Services Group
  • Lincoln, NE
  • TeleSales Specialist - Remote Location: Remote (Virtual, Work From Home) Job Description: InsuraTec Services Group is se...
  • 3/28/2024 12:00:00 AM

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Dishwasher
  • LAZLO, INC.
  • Lincoln, NE
  • Come work where it's easy to take pride in what you do. Can you imagine being part of a team that serves up more than ju...
  • 3/28/2024 12:00:00 AM

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In - Store Assembly Technician
  • Apollo Retail Specialists
  • Lincoln, NE
  • Cant stand being stuck behind a desk? Like working solo? Good with your hands? We have the perfect job for you as a Serv...
  • 3/28/2024 12:00:00 AM

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In - Home Assembly Technician
  • Apollo Retail Specialists
  • Lincoln, NE
  • As a kid, you loved taking things apart so you could put it back together. Everyone turns to you when it comes to tackli...
  • 3/28/2024 12:00:00 AM

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Chief Operating Officer
  • Independent Insurance Agents of Nebraska
  • Lincoln, NE
  • Scope of Position As UNICO Group is poised to maintain a leadership position in the ever-transitioning marketplace, the ...
  • 3/27/2024 12:00:00 AM

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Titling Specialist
  • Amur Equipment Finance Inc
  • Lincoln, NE
  • The Title Specialist is responsible for gathering documentation to send titles out to the title agencies for processing ...
  • 3/27/2024 12:00:00 AM

Lincoln is the capital of the U.S. state of Nebraska and the county seat of Lancaster County. The city covers 94.267 square miles (244.150 km2) with a population of 284,736 in 2017. It is the second-most populous city in Nebraska and the 71st-largest in the United States. The city is the economic and cultural anchor of a substantially larger metropolitan area in the southeastern part of the state called the Lincoln Metropolitan and Lincoln-Beatrice Combined Statistical Areas. The statistical area is home to 353,120 people, making it the 106th-largest combined statistical area in the United ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$133,538 to $180,273
Lincoln, Nebraska area prices
were up 0.8% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020